Competence enhancement within quality management system for the transition to MDR

Purpose and goal: ** Denna text är maskinöversatt **

PU sensor has expanded its internal competence in quality management systems and implemented the transition to MDR for its product PU sensor. Expected results and effects: ** Denna text är maskinöversatt ** The expected result has been achieved. PU sensor now has: - an updated quality management system according to ISO 13485,

- all personnel trained in the quality management system, and - complete documentation for PU sensor´s transition to MDR. Approach and implementation: ** Denna text är maskinöversatt **

The setup included workshops with quality and regulatory experts for the development and implementation of the quality management system, gap analysis for the documentation to enable the product´s transition to the MDR, and training for both QA and all other personnel. This arrangement worked well to deliver planned results.